Moxatag

In October 2015, Vernalis announced that it had also acquired the US rights to Moxatag® from Pragma Pharmaceuticals, LLC.

Moxatag® is the first and only approved once-daily formulation of the penicillin-class antibiotic amoxicillin.

Moxatag® was approved by the FDA in January 2008 for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and paediatric patients 12 years of age or older and has not been actively promoted since 2010.

Description

Sore throats may be caused by viruses or bacteria. Some infections are caused by the bacteria Streptococcus pyogenes (S. pyogenes) - that is why these infections are commonly called strep throat. Amoxicillin is an antibiotic often used to treat strep throat.

Moxatag® is the first and only once-a-day formulation of the antibiotic amoxicillin. It is approved to treat strep throat in adults and children 12 years of age or older.

MOXATAG® Indication and Important Safety Information for HCPs

INDICATION:MOXATAG (amoxicillin extended-release) Tablets is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years and older.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of MOXATAG and other antibacterial drugs, MOXATAG should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

IMPORTANT SAFETY INFORMATION:ContraindicationsPatients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or patients who have demonstrated anaphylactic reactions to beta-lactams.

Warnings and PrecautionsSerious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens, so careful inquiry about a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens should be made. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.

Clostridium difficile associated diarrhea (ranging from mild diarrhea to fatal colitis) has been reported with nearly all antibacterial agents, including amoxicillin. Evaluate if diarrhea occurs.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.

Mononucleosis rash: Ampicillin-class antibiotics should not be administered to patients with mononucleosis because a high percentage develops a rash.Risk of development of drug-resistant bacteria is increased by prescribing amoxicillin in the absence of proven or strongly suspected bacterial infection or treating prophylactically and is unlikely to provide benefit to the patient.

To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and www.vernalistherapeutics.com or FDA at 1-800 -FDA-1088 or www.fda.gov/medwatch.

Drug InteractionsProbenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.Reduced efficacy of combined oral estrogen/progesterone contraceptives may result from use of amoxicillin or other antibiotics.

Use in Specific PopulationsPediatrics: The safety and effectiveness of MOXATAG in pediatric patients younger than 12 years has not been established.

Renal Impairment: MOXATAG has not been studied in patients with renal impairment; however a reduction of amoxicillin dose is generally recommended for patients with severe renal impairment. Therefore, MOXATAG is not recommended for use in patients with severe renal impairment (CrCl <30 mL/min) or patients on hemodialysis.

Please see full Prescribing Information.

MOX-0022 04/2016

Background

MOXATAG® was approved by the FDA in January 2008 for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and paediatric patients 12 years of age or older.

IMPORTANT SAFETY INFORMATION

Severe life-threatening reactions can occur with Moxatag®. Do not take Moxatag® if you have had a previous reaction to amoxicillin or penicillin.

If you develop diarrhea that becomes severe and watery or does not go away, stop taking Moxatag® and call your health care professional. This could be a sign of a serious medical problem.

Tell your health care professional right away if you develop other infections.

Do not take Moxatag® if you have mononucleosis (mono).

Oral contraceptives may be less effective if you are taking Moxatag®.

Before taking Moxatag®, tell your health care professional if you are pregnant, plan to become pregnant or are breast-feeding. If you become pregnant while taking Moxatag®, call your health care professional.

The most common side effects of Moxatag® are yeast infection, diarrhea, nausea, vomiting, abdominal pain, and headache.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Project Status

Vernalis re-launched the product in Q4 2016

In October 2015, Vernalis announced that it has acquired the US rights to MOXATAG® from Pragma Pharmaceuticals, LLC.

MOXATAG® is the first and only approved once-daily formulation of the penicillin-class antibiotic amoxicillin.

MOXATAG® has been approved by the FDA in January 2008 for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and paediatric patients 12 years of age or older and has not been actively promoted since 2010.